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Online Resumes with "Quality Agreement"
analytical laboratory manager
I have a hands-on experience interacting with suppliers, internal customers, and subject matter experts to ensure thorough evaluation and accuracy of discrepancies and investigations, identifying root cause, coordinating corrective and preventive action plans, writing summaries, and reviewing reference documents. I am experienced in change control process for externally initiated material changes in accordance with cGMP, U...
Tags for this Online Resume: QA/QC analytical manager, FDA ICH, operations manager, laboratory setup, laboratory organization
SR. PHARMACEUTICAL QUALITY SYSTEMS & VALIDATION PROFESSIONAL
Seeking Pharmaceutical QA Position - - Full Time or Consulting Position SR. PHARMACEUTICAL QUALITY SYSTEMS AND VALIDATION PROFESSIONAL with a broad knowledge of regulatory compliance and quality control and assurance expertise in cGMP manufacturing, operations, regulatory, supply chain management, and validation as applied to aseptic parental pharmaceutical products, tablets, APIs, and medical devices. My experience in...
Ideal Companies: Pharmaceutical or Medical Device Companies, (Abbott; Abbvie; Hospira, Johnson & Johnson)
Tags for this Online Resume: North Carolina, South Carolina, Florida, Texas, Missouri, Chicago, Atlanta, Associate Director of Quality Assurance, Quality Assurance Manager, Sr. Compliance QA Manager, Associate Director of Validation, Validation Director, CAPA Management, Supplier QA Manager, Director of Supplier Assurance, CMO QA Manager, Pharmaceutical QA Manager, Medical Device QA Manager, Corporate QA Auditor, CAPA Manager, API Manufacturer, Sterile Fill Pharmaceutical Manufacturer, Medical Device Manufacturer, Sr. Quality Engineer, Oklahoma, Illinois, Milwaukee WI, Validation Manager, Internal QA Auditor
Quality Assurance Director - 4 Years of Experience - Near 08736
Accomplishments: * Led a group of 6 employees in a 24-person firm * Led a group of employees and consultants to file Icotinib IND to FDA for NSCLC * Directly handled post - IND interactions/questions with FDA * Lined up Accenture to handle eCTD publishing and submissions * Led a group to assemble and file Briefing Packages to UK, Canada, Australia and Singapore Regulatory Authorities set up and presented face-to-face meetin...
Tags for this Online Resume: Regulatory Affairs, Advertising, Business Plan, Filing, Assessments, Business Development, Chemistry, Consulting, Due Diligence, Integrate
Quality Engineer
Summary: John has been an ASQ-certified Quality Engineer and ASQ-certified Quality Auditor and a Philips-Global-certified Lead Auditor with a strong experience within medical device, pharmaceutical and contract packaging companies, while following FDA drug Good Manufacturing Practices, FDA medical device Quality System Regulation, ISO 9001 and ISO 13485 environments. He has a solid understanding with QSR supplier control sy...
Tags for this Online Resume: Compliance, Quality Assurance, Support, Technical Support, Test, Corrective Actions, Medical, Medical Devices, ISO, Audit
Quality and Regulatory Compliance
SUMMARY Expert Quality and Regulatory Compliance Professional, experienced in global processes and systems that assure appropriate cGMP/Regulatory compliance levels are maintained at all times across geographical territories. Excellent understanding of the ever-changing regulatory environments and well-versed in requirements and mitigating risks. Drives resolution. Provides leadership, guidance and solutions to complex qual...
Tags for this Online Resume: CMOS, Health Care Industry, Integrate, Training, Documentation, Intensive Care, Document Review, Filing, Planning, Services
Not Listed - 13 Years of Experience - Near 10956
SUMMARY An accomplished, charismatic and energetic leader with over 20 years progressive experience in multiple regulated industries. Expertise in Regulatory Compliance, Supplier Quality, Quality Assurance, Quality Control, domestic US cGMP (QSR) and international Quality Management System (QMS) implementation and/or improvement. Experience with US and European Regulatory Agencies and an expert facilitator for FDA and other...
Tags for this Online Resume: New Jersey, Management, people management, Facilitator, Internal audit, ISO, FDA, LMS, MDR, Supplier Quality, Quality Assurance, QMS, Validation, Quality Agreement, CAPA, QSR, cGMP
Program/Project Manager
Highly skilled innovated mechanical engineer with proven track record of achievement in design, manufacturing, project and program management experience with international Fortune 500 companies. Pragmatic Manager who specializing in driving companies to capture, growth and sustain profitably and market share. Provides vision and strategies to transforms corporate initiatives and projects to lucrative realities Expert in mec...
Ideal Companies: General Atomics, illumina, Sony
Tags for this Online Resume: LeanManufacturing, Project Management, Quality Assurance, Technology Transfer, Consumer Electronics, Biomedical, GD&T, Process Improvement, Mechanical Design, SolidWorks, Program Management, New Product Introduction, Manufacturing Engineering
Director of Supply Chain - 20 Years of Experience - Near 33511
QUALIFICATIONS: 1977 - 2013 Verizon Communications Accomplished with a dynamic 36-year history of leadership in multiple operations including 13 years of executive level management within Verizon Communications. Defined as a results focused executive with key roles/responsibilities dedicated to improving shareholder value and company growth. Director Supply Chain Management - Logistics Services Director Supply Chain Managem...
Tags for this Online Resume: 3PL, Account Management, Audit, Business Requirements, Capital Expenditures, Customer Relationship Management, Data Analysis, English Language, Financial, Forecasting
Quality Assurance Director - 20 Years of Experience - Near 33545
BSI ISO 13485:2003 Lead Auditor (TPECS) Certification - Certificate: 7930649-76913 * Hired and entrusted by B Braun McGaw of Puerto Rico and LeMaitre Vascular to implement a wide-array of corrective actions and systems resulting from 3 FDA warning letters. Subsequently after new systems implementation received 0 FDA 483 observations for a combined period of 12 years. * Built company-wide shared quality visions which complet...
Tags for this Online Resume: Documentation, Quality Assurance, Compliance, Pharmaceutical Industry, Quality, Quality Control, Regulatory Affairs, Medical Devices, Pharmaceuticals, Regulatory Compliance
Director of Quality - 24 Years of Experience - Near 11801
Professional Summary Highly effective professional offering 30 years of US global quality leadership experience developing strategies, improvement action plan and solutions. Dedicated leader to bring organizations together, focusing on hi performance culture leading to improvement and efficiency. Built fully engaged team that is motivated to achieve metrics and deliver ROI. Lead and empowered cross functional teams to impro...
Ideal Companies: end of the year 449.00 + 4 months of our service. resume rewtire and cover letter.
Tags for this Online Resume: TQM (Total Quality Management), Manufacturing, Assessments, Audit, Quality, Quality Management System, HACCP, Continuous Improvement, PCQI, Supplier site and internal audits, USDA, FDA, ISO 9001, SQF, BRC, ISO 22000, ERP, OOS, Investigation, CAPA, NCR
A seasoned, results-oriented analytical business professional with progressive experience and accomplishments across multiple industries. Solid experience in successfully managing large and complex global business portfolios. Enthusiastic self-starter abl
My long term goal is to function in an Executive Leadership position where I can shape strategy and structure sustainable processes that optimize the organization for which I have oversight. This will be achieved by continually developing transferable skills in my progressive roles and responsibilities.
Ideal Companies: Coca Cola, Georgia Pacific, Koch Industries
Tags for this Online Resume: Management, Procurement, Compliance, Manufacturing, Medical Devices, Quality Assurance, Quality, Quality Management, Business Professional, Supplier Manager, Vendor Management, Supply Chain, Continuous Improvement, Lean and Six Sigma Methodologies, Performance Monitoring and Improvement
Civil Service - 17 Years Experience - Near 85712
Adjudicating Criminal/Civil Hearings * Policy Development * Strategic Planning and specializing in alcohol counseling to success in life.
Ideal Companies: Nike, Climber.com. Raytheon, Booze-Allen, Boeing, General Dynamics, Caterpillar.
Tags for this Online Resume: Management, Corrective Actions, Quality, Quality Assurance, First Aid, Medical, Medical Terminology, Training, Strategic Planning, Curriculum Development
